Ending the Epidemic Interventions in the Dental Setting - UH3

NCT06890988 | Recruiting

• 2 other identifiers: AAAT8854 - UH34UH3DE031258
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to use information technology (IT) to support the efficient delivery of HIV prevention and care best practices in the dental care setting.

Conditions

HIV-1-infection

Keywords

clinical decision support; acceptability; feasibility; implementation science; HIV testing

Outcome Measures

Primary Outcomes (1)

• Proportion of patients that complete point of care HIV testing out of patient encounters receiving clinical decision support (CDS) prompts for HIV testing

  Proportion of patients receiving clinical decision support (CDS) prompts for HIV testing that complete point of care HIV testing over the intervention period under the Enhanced versus Standard Dental Care Models.

  10 months after start of each arm

Secondary Outcomes (5)

• Provider acceptability of multicomponent HIV service package in dental clinics

  5-10 months after start of each arm

• Provider feasibility of multicomponent HIV service package in dental clinics

  5-10 months after start of each arm

• Proportion of patients receiving CDS prompt for HIV testing that complete subsequent HIV testing outside of the dental clinic

  Within 12 months following dental visit

• Proportion of patients receiving CDS prompt for HIV testing with subsequent appointment at an HIV prevention clinic

  Within 12 months following dental visit

• Proportion of patients receiving CDS prompt for HIV testing subsequently prescribed pre-exposure prophylaxis (PrEP) medication

  Within 12 months following dental visit

Study Arms (2)

Standard Dental Care Team model

PLACEBO COMPARATOR

Multicomponent HIV Service Package delivered without a Care Navigator

Other: Multicomponent HIV Service Package

Enhanced Dental Care Team model with a Care Navigator

EXPERIMENTAL

Multicomponent HIV Service Package delivered with a Care Navigator

Other: Care Navigator; Other: Multicomponent HIV Service Package

Interventions

Care Navigator OTHER

The Care Navigator will be added to the dental team as an added resource to: 1. Champion the use of the multicomponent HIV intervention in the dental clinic among clinic administrators, residents, dental hygienists, dental assistants, and other dental team staff. 2. Provide technical assistance 3. Provide logistical assistance ; and 4. Support dental team in educating patients about HIV prevention and treatment options

Enhanced Dental Care Team model with a Care Navigator

Multicomponent HIV Service Package OTHER

Multicomponent HIV Service Package consisting of: 1. Clinical Decision Support (CDS) within electronic medical record (EMR) system to help providers identify patients who would benefit from HIV screening or re-engagement in HIV care. 2. Point-of-care HIV testing in the dental clinic. 3. Patient and provider-facing educational materials to support providers in discussing HIV prevention options (for patients who test HIV negative) and treatment (for patients who test HIV positive or are out of HIV care) options.

Enhanced Dental Care Team model with a Care Navigator; Standard Dental Care Team model

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Member of the Dental Team (Provider, Hygienist, Dental Assistant, Care Navigator) at one of the randomized sites with direct patient contact
• Able to provide written informed consent.

You may not qualify if:

• \- Inability to provide written informed consent.

Sponsors & Collaborators

• Columbia University: lead
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator

Study Sites (3)

Columbia University Irving Medical Center / NewYork-Presbyterian Hospital

New York, New York, 10032, United States

RECRUITING

Weill Cornell Medical Center / NewYork-Presbyterian Hospital

New York, New York, 10065, United States

NOT YET RECRUITING

NYP-Queens

Queens, New York, 11365, United States

NOT YET RECRUITING

Central Study Contacts

Michael Yin, MD, MS

CONTACT

212-305-7185; mty4@cumc.columbia.edu

Nadia Nguyen, PhD

CONTACT

nn2442@cumc.columbia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Model Details: Sites will be randomized to one of 2 arms: (AB) Standard Dental Care Team model followed by crossover to an Enhanced Dental Care Team model with a Care Navigator, or (BA) Enhanced Dental Care Team model with a Care Navigator followed by crossover to a Standard Dental Care Team model.

Study Record Dates

• First Submitted: March 14, 2025
• First Posted: March 24, 2025
• Study Start: March 31, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

US (3)